About FDA
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CDRH FOIA Electronic Reading Room
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Fresenius Medical Care 510k's
K030497, Fresenius Medical Care North America, Naturalyte Granuflo Dry Acid Concentrate (PDF - 4.4MB)K070177,Fresenius Medical Care North America, Naturalyte Liquid Acid Concentrate (PDF - 5.7MB)K071387, Fresenius Medical Care North America, Naturalyte Sodium Biocarbonate Liquid Concentrate (PDF - 2.5MB)K911459, Fresenius USA;, Inc., Granulyte Powder Dialysate Concentrate and Mixing System (PDF - 5.2MB)K922005, Fresenius USA, Inc, Granulyte Dialysate Concentrate (PDF - 2.3MB)
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MINIMEDS Paradigm Quick-Set Infusion Set
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510(k) Submission for Gibeck, Inc.
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Frequently Requested Documents
K032417 AM2 Pat Inc. Heparin Lock Flush Syringe (PDF - 303KB)510(k) Submission for AM2Pat Intravascular Catheter (PDF - 13.5MB)K053656 Tyrx Pharma Inc. Tyrx Antimicrobial Mesh (PDF - 35.3MB)K896422 Burron Medical Inc. Burron Ambulatory Drug System (PDF - 3MB)K080238 Masimo Rainbow Set Radical 7 Co-Oximeter (PDF - 53.3MB)K012628 Gynecare Tension-Free Vaginal Tape (PDF - 11.7MB)K020251 Paragon Infusion System (PDF - 3.2MB)K020660 Homepump Eclipse C-Series (PDF - 3.4MB)K020862 I-Flow Elastomeric Pump (PDF - 2.6MB)K023827 Paragon Infusion System with Bolus (PDF - 2.9MB)K023883 Homepump Eclipse C-Series Painbuster (PDF - 2.5MB)K030661 Stryker Painpump (PDF - 18.2MB)Stryker PainPump 2 (PDF - 18MB)K031249 Stryker Instruments Modification to Stryker Pain Pump (PDF - 9.7MB)K040337-I-Flow Elastomeric Pump (On-Q, Painbuster, C-Bloc, Homepump) (PDF - 10MB)K041482-Decapinol Oral Rinse (PDF - 32.8MB)K043456-Modification to Soaker Catheter (PDF - 3.7MB)K982946-Painbuster Infusion Kit (PDF - 17.6MB)K033568-Gynecare TVT Obturator System (PDF - 2.4MB)K041816-RTX3320PSTN Wireless Telehealth Gateway (PDF - 6.6MB)K051320 Satellite Spinal System (PDF - 5.6MB)K060415-Modification to Satellite Spinal System (PDF - 7.7MB)K972173 I-Flow Medi-SIS Syringe Infusion System (PDF - 7.5MB)K980558-PainBuster Infusion System (PDF - 6.9MB)K984063 I-Flow Paragon Basal-Bolus Admin Set (PDF - 5.4MB)K984441 I-Flow KVO Check Valve Accessory Model EV-0001 (PDF - 4.9MB)K984502 I-Flow Nerve Block Infusion Kit (PDF - 19.4MB)K984638 I-Flow Paragon Bolus Accessory Kit (PDF - 3.8MB)K991543 I-Flow Intraop Cathete (PDF - 4.9MB)K031011 Ligasure 5MM Laparoscopic Sealer-Divider, Model LS1500 (PDF - 9.1MB)K072629, DigiMatch ROBODOC Surgical System (PDF - 57.1MB)K000306 Depuy Orthopaedics, Inc. Pinnacle Acetabular System (PDF - 2.5MB)K003523 Depuy Pinnacle Acetabular Cup Liners (PDF - 3MB)K013718 Gynemesh Prolene Soft (Polypropylene) Nonabsorbable Synthetic Surgical (PDF - 7.4MB)K000306 Depuy Pinnacle Acetabular System (PDF - 2.7MB)K001523, Depuy Orthopaedics, Ultima Metal on Metal Acetabular Cup (PDF - 4.3MB)K022086-Invitrogen Corp-AIM-V Medium (PDF - 12.1MB)K022869 I-Flow Soaker Catheter (PDF - 3.4MB)K023318 I-Flow Elastomeric Pump with Bolus (PDF - 2.7MB)K031249 Modification to Stryker PainPump (PDF - 10MB)K041263 Neuroguide Analysis System (PDF - 32.2MB)K041482 Decapinol Oral Rinse (PDF - 26.8MB)K051503 UGYTEX Dual Knit Mesh (PDF - 2.2MB)K052117 I-Flow Elastomeric Infusion Pump (PDF - 16.7MB)K052401 Gynecare TVT Secur System (PDF - 2.1MB)K053120-Sterile Field Saline and Heparin Lock Flush Syringes (PDF - 3.3MB)K990425-I-Flow Sidekick Infusion Kit (PDF - 11.7MB)K991513-I-Flow Homepump C-Series (PDF - 5.4MB)K061899 - Evotech Intefrated Endoscope Disinfection System (PDF - 21.2MB)K023318-I-Flow Elastomeric Pump with Bolus (PDF - 2.7MB)K052117-I-Flow Elastomeric Infusion Pump (PDF - 16.7MB)K022869-I-Flow Soaker Catheter (PDF - 3.4MB)K003523, Depuy Pinnacle Acetabular Cup Liners (PDF - 3.3MB)K083839-Avaulta Solo Synthetic Support System (PDF - 1.6MB)K082571-Avaulta Support System (PDF - 2.1MB)K051503-UGYTEX Dual Knit Mesh (PDF - 2.2MB)K071026 BD GeneOhm StaphSR Assay (PDF - 1.9MB)K080118-Zeltiq-Aesthetics CLN1 Dermal Cooling Device (PDF - 56.7MB)K090094-Zeltiq Powered Laser Surgical Instrument (PDF - 71.8MB)K060978-Roche-Coaguchek XS System (PDF - 6.4MB)K062925-Roche-Coaguchek XS System for Patient Self-testing (PDF - 9.4MB)K051401 On Q Catheter, On-Antimicrobial Catheter, Soaker Catheter, I-Flow Cath (PDF - 33.7MB)K984146 I Flow Paragon Infusion Kit (PDF - 15.2MB)K992072 I Flow Bolus Accessory Set (PDF - 3.5MB)K994374 I Flow Soaker Catheter (PDF - 4.6MB)K992072 I Flow Bolus Accessory Set (PDF - 3.5MB)K984146 I Flow Paragon Infusion Kit (PDF - 15.2MB)K040627 Depuy Orthopaedic, ASR System (PDF - 18.7MB)- K073356, Medtronic Minimed Paradigm insulin Infusion Pump, models MMT-512, 712, 515 (PDF - 4.9MB)
K093775 C.R. Bard, Inc Sapiens Tip Location System (PDF - 170.7MB)K062426 DePuy Orthopaedics, Inc (PDF - 31.5MB)K081960 Align Tech Invisalign System (PDF - 53.6MB)K965156 Johnson & Johnson Professional, Inc, Ultima Unipolar Head & Adapter sleeves (PDF - 3.2MB)K042037 Biomet, Inc. Prosthesis, Hip, Semi-Constrained M2A Magnum System (PDF - 11MB)K011676 Vivant Medical, Inc., Vivawave Microwave System (PDF - 57.1MB)K023098 McKinley Infuser, Pump, Infusion, Elastomeric (PDF - 62.3MB)K073413 Depuy Orthopaedics, Inc., Depuy ASR 300 Acetabular Cup System (PDF - 1.3MB)K032642 McKinley, Inc., Infusion Pump (PDF - 5.7MB)K083862 Medapps 2.0 Remote Patient Monitoring System (PDF - 25.1MB)K945462 Block Drug Company, Inc, Super Poli-Grip Denture Adhesive Cream (PDF - 4.3MB)K063835 Smith and Nephew, Inc., Allevyn Ag Dressings (PDF - 93MB)K082358, Smith & Nephew, Inc, Patient Matched Cutting Blocks (PDF - 35.8MB)K002883, Depuy Orthopaedics Pinnacle Metal on Metal Acetabular Cup Liners (PDF - 2.1MB)K011110 Biomet, Inc. Prosthesis, Hip, Semi-Constrained M2A Acetabular System (PDF - 6.6MB)K032642-McKinley, Inc., Infusion Pump (PDF - 5.7MB)K051002-Ethicon-Endopath Endocutter 60 Endoscopic Linear Cutter (PDF - 17.6MB)K051401-On-Q Catheter, On-Antimicrobial Catheter (PDF - 33.7MB)K061053-Neuronetics- NeuroStar TMS Systems (PDF - 403.4MB)K063712-Avaulta Plus Biosynthetic Support System (PDF - 2.9MB)K063835-Smith and Nephew, Inc., Allevyn Ag Dressings (PDF - 93MB)K073413-Depuy Orthopaedics, Inc., Depuy ASR 300 Acetabular Cup System (PDF - 1.3MB)K082358, Patient Matched Cutting Blocks (PDF - 35.8MB)K082402 Imaging Therapeutics OSDX HIP BMD System (PDF - 11.7MB)K083691-MicroMRI-Bonevue (PDF - 30.4MB)K083862-Medapps 2.0 Remote Patient Monitoring System (PDF - 25.1MB)K090245, Medlingo LTD, Solo Insulin Patch Pump (PDF - 67.6MB)K090525-Palomar-LOI System (PDF - 55.4MB)K091496 MIDWEST R.F. LLC.- MEP-90 HAIR GROWTH STIMULATION SYSTEM (PDF - 22.3MB)K945462-Block Drug Company, Inc, Super Poli-Grip Denture Adhesive Cream (PDF - 4.3MB)K982256-McKinley-Outbound Disposable Syringe Infuser and OB 2 Pump (PDF - 4.1MB)K980558-PainBuster Infusion System (PDF - 6.9MB)K022086-Invitrogen Corp-AIM-V Medium (PDF - 12.1MB)K032417 AM2 Pat Inc. Heparin Lock Flush Syringe (PDF - 303KB)K063530-I-Flow-Elastomeric Infusion Pump (PDF - 24.8MB)K073449, materialise N.V. Surgicase System (PDF - 38.8MB)K080521-Zeltiq Aesthetics Dermal Cooling Device (PDF - 31.5MB)K080991, Depuy ASRXL Modular Acetabular System (PDF - 13.8MB)K063234-I-Flow-ON-Q Introducers (PDF - 32.6MB)K033269-Ethicon-Endopath Endocutter Gray Cartridge (PDF - 11.3MB)K071512-Gynecare Prolift +M Pelvic floor Repair System (PDF - 33.5MB)K981318 Dual Lock Cap-Baxter Healthcare (PDF - 5.8MB)K083716 Church & Dwight First Response Early Result Pregnancy Test (PDF - 71.6MB)K053536, Zimmer GMBH, Durom Acetabular component and Metasul Large Diameter Heads (PDF - 46MB)K093489 In Vision Plus Rymed Tech (PDF - 91.7MB)K905188-TELEDYNE Water Pik-Oral Irrigation (PDF - 3.8MB)K103785 - MIM Software - Mobile MIM (PDF - 36.5MB)K102470-Covidien - LIGASURE CURVED SMALL JAW OPEN SEALERDIVIDER (PDF - 277.6MB)K093745 - Lifescan Inc - One Touch Verio Blood Glucose Monitoring System (PDF - 306.3MB)K092602-Abbott-Freestyle Lite Blood Glucose Test Strips (PDF - 68.9MB)K090820-TRIA LASER HAIR REMOVAL SYS (PDF - 66.3MB)K080620 3M Tegaderm Wound Dressing Modification (PDF - 14.9MB)Ghosh - Contact lens presentation at 15th CL symposium on 03-18-11 (PDF - 363KB)Kiang - Contact lens presentation at 15th CL symposium on 03-18-11 (PDF - 371KB)K072343-NUVASIVE-Maximum Access Surgery (PDF - 33.7MB)K072505 (PDF - 250.9MB)K072741-Ingfertility-Pre Va Vaginal Lubricant (PDF - 119.6MB)K072845 Vapotherm, Inc. Precision Flow (PDF - 299MB)K043065- Edwards Lifesciences - Arterial Pressure Cardiac Output Oximtry Monitor (PDF - 124.9MB)K100635 - Arrow - Arrowgard Evolution Antimicrobial Catheter (PDF - 408.6MB)K093930-Bayer Healthcare Didget Diabetes Management Software (PDF - 568.6MB)K020988 Breg Inc. Elastomeric Infusion Pump (PDF - 3.4MB)K013928 Breg Elastomeric Infusion Pump (PDF - 2.8MB)K002073 Breg Elastomeric Infusion Pump (PDF - 10.9MB)K003611 Breg Elastomeric Infusion Pump (PDF - 2.3MB)K002321 Breg Elastomeric Infusion Pump (PDF - 3.2MB)K983454 Breg Elastomeric Infusion Pump (PDF - 10.8MB)K041714 Breg Infusion Pump (PDF - 10.7MB)K080591 Pharos Life Corporation Tanda Skincare System (PDF - 135.2MB)K083042 Nurse Assist, Inc. Wound Flush (PDF - 10MB)K103184 Home Skinovations (PDF - 19.5MB)K082298-Home Skinovations (PDF - 13.9MB)K072906 Home Skinovations (PDF - 14.3MB)K100130-PATH FAST cTnl-ll Test Mitsubish chemical (PDF - 20.9MB)K112930 Mobile MM (PDF - 43.3MB)K082088 Mako Surgical Patellofemoral Knee Implant System II (PDF - 24.8MB)K091457 Nexstim Eximia Navigated Brain Stimulation System (PDF - 514.6MB)K061866-Thermotek, Inc., Nanotherm, Vascutherm (PDF - 44.3MB)K103244 Q-Mix 2 in1 Endodonic Irrigating Solution (PDF - 1.9MB)K102598-Hi-Dow International-Tens Model JQ-5C (PDF - 123.1MB)K080029 - Mako - Patellofemoral Knee Implant System (PDF - 46.2MB)K100349- Johnson and Johnson Vision Care Vistakon (PDF - 291.4MB)K110301 - Homeskin - Silknfx (PDF - 37.4MB)K120306 - Minntech Rapicide OPA 28 (PDF - 16.2MB)K061711 - Cook Biotech - Oasis Wound Matrix (PDF - 3.2MB)K111346-Calgary Scientific, Inc. Resolution MD Mobile (PDF - 16.5MB)
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Pathway Genomics Genetic Health Report
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P920015: Medtronic Sprint Fidelis (PDF)
Recall Letter Z-0060-2008 thru Z-0070-2008 (PDF - 31KB)P920015: Medtronic Sprint Fidelis (PDF) - Annual Reports 11, 12, 13, and 14 (PDF - 12.2MB)P920015: Medtronic Sprint Fidelis - Supplement 25 and Supplement 27 (PDF - 835KB)P920015: Medtronic Sprint Fidelis - Supplement 29 and Supplement 32 (PDF - 3.9MB)P920015: Part 1 - Medtronic Defibrillator Clinical and Bench Testing (PDF - 211.1MB)P920015: Part 2 - Medtronic Defibrillator Clinical and Bench Testing (PDF - 187.3MB)P920015: Part 3 - Medtronic Defibrillator Manufacturing and Testing (PDF - 145.4MB)P920015: Medtronic Defibrillator - Attachments to Letter to Rep. Waxman (PDF - 102.1MB)P920015: Part 4A - Medtronic Sprint Fidelis - Defibrillator Manufacturing (PDF - 68.3MB)P920015: Part 4B - Medtronic Sprint Fidelis - Defibrillator Manufacturing (PDF - 47.8MB)P920015: Part 4C - Medtronic Sprint Fidelis - Defibrillator Manufacturing (PDF - 48.8MB)P920015: Part 4D - Medtronic Sprint Fidelis - Defibrillator Manufacturing (PDF - 29.6MB)P920015: Part 4E - Medtronic Sprint Fidelis - Defibrillator Manufacturing (PDF - 77MB)P920015: Part 5 - Medtronic Sprint Fidelis - Defibrillator Manufacturing (PDF - 40.5MB)Letter re: P920015/R014 dated March 10, 2008 (PDF - 151KB)P920015: Amendment to Pre-IDE I020145 for Medtronic Model 6948 and 6949 Leads (PDF - 244KB)FDA March 7, 2007 Letter to Medtronic (PDF - 448KB)
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510(k) Submission for Tyrx Pharma INC
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